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Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259557
First Posted: December 14, 2010
Last Update Posted: April 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medy-Tox
  Purpose
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.

Condition Intervention Phase
Essential Blepharospasm Drug: Botulinum Toxin Type A Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm

Resource links provided by NLM:


Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • the change rate of Jankovic Rating Scale score [ Time Frame: 4weeks ]
    To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).


Secondary Outcome Measures:
  • the change rate of Jankovic Rating Scale scale [ Time Frame: 0 week, 16weeks(or retreatment point) ]
    To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).

  • the change rate of Blepharospasm Disability Index [ Time Frame: 0week, 4weeks, 8weeks, 16weeks(or retreatment point) ]
    To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.

  • Global assessment about the improvement [ Time Frame: 4weeks ]
    To evaluate the Global assessment about the improvement at 4weeks post treatment.

  • the duration of efficacy [ Time Frame: retreatment point or 16 weeks ]
    To evaluate the duration of efficacy


Enrollment: 110
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum toxin type A(Meditoxin®) Drug: Botulinum Toxin Type A
2 times, Intra-muscular injection, Maximum dosage total 60U
Other Names:
  • Meditoxin
  • Neuronox

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged above 18
  • Subjects who was diagnosed with Essential Blepharospasm
  • Subjects who voluntarily Signed written informed consent
  • Subjects who can adhere to protocol and study requirements

Exclusion Criteria:

  • Subjects with known history of allergy considered due to Botulinum toxin type A
  • Subjects who have received botulinum toxin A type within 3 months
  • Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
  • Subjects who are participating in other clinical trials
  • Pregnant or lactating female Subjects
  • Subjects who are not eligible for the study at the discretion of the Investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259557


Locations
Korea, Republic of
Sevrance Hospital
Seoul, Korea, Republic of, 120-752
Seoul St.Mary Hospital
Seoul, Korea, Republic of, 137-040
Chung-Ang Univesity Yongsan Hospital
Seoul, Korea, Republic of, 140-883
Sponsors and Collaborators
Medy-Tox
Investigators
Principal Investigator: Jaechan Kim, M.D., Ph.D. Chung-Ang university Yongsan Hospital
  More Information

Responsible Party: Yujin Sun / CRA, Medytox
ClinicalTrials.gov Identifier: NCT01259557     History of Changes
Other Study ID Numbers: MT-PRT-BP02
First Submitted: November 25, 2010
First Posted: December 14, 2010
Last Update Posted: April 25, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents